Pharmalab India Pvt. Ltd. GIDC, Rajkot, Gujarat

We are offering water systems. Over the last 30 years pharmalab has been a leading supplier of plants producing water for injection, which meets international standards, including usp, ip, bp and jp. The plants are manufactured as per fda - current good manufacturing practices (cgmp) and asme requirements and follow the basic principle of distillation by thin film evaporation.

cGMP and Hygienic design to meet all hospital needs Optimized processes for a complete wash: A powerful washing system with a unique spray arm design to ensure effective spray pressure and a sweeping spray pattern Efficient detergent usage – the powerful washing reduces the reliance on chemicals to achieve required results A three tank arrangement to perform multiple activities simultaneously reducing the cycle time Turbulent air drying to help achieve better and quicker drying Fully automatic system with customizable cycle option and automatic detergent dozing provides for an easy validated operation The washer complies with the medical device directive 93/42/EEC, EN 15883-1 and EN-15883-2, HTM 20130 and the medical devices quality management systems requirements for regulatory purposes ISO 13485     Pharmalab’s Washer Disinfector is operated through a PLC ensuring the complete process is automatically operated and controlled. The operation of the cycle is done through the easy to use coloured touch screen MMI. These features not only make the washer extremely easy to use but also reduce the chances of human error considerably. The Washers inbuilt logic controls the temperature and time of the cycle based on the A0 value to be achieved, ensuring the cycle complies with the required EN 15883-1 and 15883-2 guidelines.

This filter press is offered for filtration of solids from liquid in comparatively higher batch sizes. The Press can be precisely sized for the required filtration area and cake holding capacity. It finds application in pre-filtration of sterile products, syrups, beverages etc. It is available in plate sizes of 20 x 20, 40 x 40, 60 x 60 cms. Size 60 x 60 cms is common in Beverages industry for the filtration of Sugar Syrup of higher brix value. It is provided with Hydraulic Power Pack as a closing device for units having higher filtration area. Unlike the horizontal plate filter press, these units can be used for reduced filtration area by removing a few number of plates. In certain cases a blockage plate can help to meet unwarranted conditions. Another distinct advantage is the usage of the “by-pass” plate which facilitates two-step filtration, e.g. 10 microns followed by 5 microns.

Air & steam mixture (Ventilator) terminal sterilizer is an efficient method for terminal sterilization of large volume parental in plastic pouches, solutions in open or semi closed containers, glass containers, vials or ampoules, contact lenses in blisters, pre-filled syringes etc. The key feature of this method is that the product is completely dry after sterilization. The load is introduced on appropriate carriages and trays into the chamber, followed by allowing steam to enter the chamber through a perforated conduit located at the top. One or more fans (blowers) are located on the sealing of the chamber. The depth of the chamber would decide the number of fans required. The blowers help in circulation of steam and rapid homogenization of air (already present in the chamber) with steam. The system provides uniform heating of the load. Counter balance of pressure in the container is achieved by introducing filtered air into the chamber system. After the sterilization phase, the product goes through a cooling phase. The finned tube heat exchangers mounted on the side-walls of the chamber carry chilled water allowing the product temperature to decrease. At the end of the process the product is sterile, cool and dry.   APPLICATIONS Sterilization of filled containers of HDPE/LDPE, multi-layer pouches/bottles & glass bottles After sterilization the product packaging comes out totally dry unlike the bottles sterilized in super-heated water spray sterilizer. Large volume infusion/parenteral solution in plastic bottles & plastic bags Blood bags Pre-filled syringes or ampoules Blister pack products Contact lenses FEATURES Recirculation blowers with double (optional) mechanical seal & a powerful electric motor to ensure uniform mixing of steam & air. Finned tube heat exchangers for effective and rapid cooling of the load Baffle plates for horizontal flow to optimize temperature distribution Automatic sliding doors for ease of operation Guide rails for easy movement of product carriages inside the chamber Optional automatic loading —unloading system Single or double door, semi-automatic hinged type or automatic sliding type Temperature & pressure monitoring inside the chamber PLC & HMI based control system with provision for SCADA connectivity. Range of alarms & safety devices for product, process & operator safety Rapid cooling cycle available for shorter cycle time Provided with extensive documentation

ULTRASONIC CLEANER Efficient tank design and the optimum transducer selection and placement to ensure an uniform power of 1200W Our washers come with a standard 30KHz ultrasonic frequency with other frequencies available on request Critical cycle parameter control: The washer automatically monitors, control and records the ultrasonic power, tank temperature and the cycle time throughout the cycle The washer is provided with luer lock arrangement for circulation of water and effective cleaning Rinsing is done through powerful spray nozzles EASE OF OPERATION: The ergonomic design coupled with the sophisticated automation makes the washer extremely easy to use. Optimum loading height Automatic process-Pre-washing, water filling & detergent dozing, Ultrasonic washing with process parameter control, draining of tank and rinsing Easy chemical can replacement with low level alarms

Pharmalab’s Tube filling and cartoning machine delivers best packaging quality standards with robust design and good manufacturing practice. The machine is designed with cost effective measures which requires minimal maintenance and achieves high operating efficiency. Tube filling machine capacity ranges from 40 to 180 Tubes per Minute. FEATURES Precise automatic infeed. Print mark registration and sealing. Leister (Switzerland) make heating gun. PLC-HMI based operation. Overload clutch protection for longer life. Easy changeover with change over kit.s Flame proof electrical panels “(optional)”. Tube cleaning with dedicated suction blower. GMP model with all sides cover. Confirmatory to European safety standard. No tube-No fill, No seal, No cutting. One Machine suitable for aluminum, laminated and plastic tubes. Auto collection of Laminated tube residual.

This is used for precise labelling on single or double sides simultaneously, for containers of any size and shape. The machine operates at the speed of 100 / 200 / 300 containers per minute, depending upon the label length. Containers of different shapes and sizes can be accommodated on the same machine with or without the need for change parts. The latest SERVO technology makes for precise placement of label and also for high output. PSC/HS For Ampoules /Vials This is for applying labels vertically on ampoules / vials and other thin-diameter containers at a high speed of 200-400 containers per minute. The unique operating feature of this machine is its interruption-free one-touch synchronized operation. Moreover, speeds can be changed on-line from the control panel, which displays labelling speeds. PSC/PLC For Round (Diff. Dia.) / Perfect Square Containers. This is used for full / partial wrap-around labelling on round / square containers of different sizes. The machine operates at the speed of 100 / 200 / 300 containers per minute depending on the lable length. Separate drives for conveyor, wrap-around and space creators are useful for precise labelling on various products with varying label sizes.  

We offer sterilizers. Sterilization is a critical part of the manufacturing process. Sterilization as a process is governed by stringent conditions and standards set by regulating authorities and pharmacopeias.

The Sterility Test Isolator SKANFOG® STI is the most advanced isolator for testing pharmaceutical samples for sterility (STI). Installation in labs and an accelerated decontamination time are facilitated by the once-through air handling system and the integrated catalytic converter for H2O2. The availability of the isolator has improved substantially, so a high testing frequency can be obtained. SKANFOG® STI is manufactured in India with SKAN’s technology and expertise. CUSTOMERS NEEDS Sterility testing in an aseptic environment for perfect test results Fast and easy testing performance Quick installation in the laboratory Low running costs compared to clean room operations FEATURES Integrated SKANFOG® H2O2 decontamination reaching a 6 log reduction of G. stearothermophilus Fast decontamination cycle of the chamber Integrated catalytic converter to break down H2O2 – no HVAC installation required Safe change return air filter: isolator is suitable for testing hazardous products BRIGHT RANGE OF SERVICES Complete documentation according GAMP 5.0 Installation and commissioning Isolator qualification IQ/OQ Decontamination cycle development Microbiological qualification Documented operator training

Sterilization (or sterilisation) in simple terms, refers to any process that effectively kills or eliminates transmissible agents (such as bacteria, viruses, spore forms etc.) from a surface, equipment or biological culture medium.Sterilization can be achieved through application of heat, chemicals, irradiation, or filtration. Of these, heat (steam) sterilization is proven to be the most effective.A minimum temperature-time relationship must be maintained throughout all portions of load to accomplish effective sterilization. Exposure time depends upon size and contents of load, and temperature within the sterilizer. At the end of the cycle, re-evaporation of water condensate must effectively dry contents of the load to maintain sterility.   FEATURES Control system as per 21CFR part 11. Dimple jacket of SS 316L provided for enchanced / uniform and temperature distribution (within ±1oC during the sterilization phase. Bioseal: A biological safety barrier separates the sterile and non-sterile zon. Integration of sterile section with isolator. Machine gasket groove for the door. Air detection system for porus load. Rack & Pinion arrangement for door movements. Seal water recirculation arrangement. Temperature control through PLC using floating sensor mechanism. Electric Steam Generator (Optional). Provided with Pure steam sampling arrangement with heat exchanger for easy draw of sample in aseptic and safe temperature condition(Optional

We design, manufacture and supply Soft Gelatin Plant equipments covering all the process equipments leading up to the point of the encapsulating machine under stringent compliance with latest cGMP norms. Most important parameters for any Soft Gel Plant which are to be meticulously and articulately incorporated in the design of the process equipments are as follows: Agitator of Gelatin Cooker is a special kind of Contra-rotating type Anchor having Triangular Blades for imparting low shear mixing action to highly viscous Soft Gelatin mass for intimate mixing. Hydraulic Lifting System for the top cover of the Gelatin Cooker PLC Programmed (optional) for Dual speed agitation to reaction mass of Gel cooker as per the defined recipe Specially constructed Gelatin Feed Tank with electronic heating system Medicament Mixing & Homogenizing Vessel Multi-purpose Mixing & De-aeration Unit with SS Control Panel for carrying out the following operation Mixing of Medicament Colour Mixing in Gelatin mass De-aeration of Gel mass Hydraulic Lifting of Agitators for different operations with quick release coupling for agitator change/cleaning operation Heat traced transfer pipe line for feeding Gelatin in to the Encapsulating Machine Vacuum Control System for De-aeration in Gelatin Cooker Strict compliance to cGMP as per the international standard norms SS 316L contact parts mirror polished to less than 0.5 Micron RA & SS 304 Non-Contact parts matt finished. 100% drainable, crevice and dead leg free internal surface “CE” marked Equipments are offered with Third Party Inspection & All Electrical Control with ERTL Approval & Test SPECIFICATIONS Glycerine/ Sorbitol Storage Vessels Raw Gelatin Feed Tanks Gelatin Cooker Gelatin Feed Tanks Plain/Jacketed Medicament Storage Tanks Medicament Mixing and Gelatin Colour Mixing and De-aeration Unit with Hydraulic Lift system Medicament inline Homogenizer & Lobe Pump SS Working Platform Instrumentation & Piping Utility System of Hot Water & Vacuum Mobile Auto CIP Unit Gelatin Cooker 100 L to 2000 L Cooker capacity APPLICATIONS Processing of soft gelatin capsules

We design and supply Mobile and Fixed CIP & SIP Units for sanitization and sterilization. The units are custom made, modular, skid either automatic or semi-automatic models as per the requirement for cleaning and sterilization.   CIP UNIT CIP Tank/Tanks, Jacketed/Non-Jacketed Supply Pump/Return Pump Heater as required Dosing Tanks/Pumps Inter-connected Pipings/Valves/Instrumentation Automation System/Control Panel SS Skid/SS Platform MOBILE SIP UNIT Pure Steam Header with PI, TI & Safety Valve Condensate Header with sterile steam trap unit and Temp. Sensor PLC Control Panel with Time/Temperature control program, printer, alarm etc. as required SS Mobile Stand with PU Castors SPECIFICATIONS: Sanitary Design to meet all cGMP criteria Contact parts : SS 316L, Mirror polished & EP to All Non – Contact parts : SS 304 Matte finish Orbital Tube welding Automation as per MCA & USFDA 21 CFR Part 11 Built to custom requirement 100% Drainability GMP documentation like DQ, FAT, IQ, OQ & PQ Protocols Site Installation & Commissioning Documented Output of cleaning & sterilization cycles APPLICATIONS: Pharmaceutical Biotechnology Food Beverage

FEATURES PLC controlled machine Customised infeed & collation Automatic infeed arrangement Cooling after heat shrinking SS 304 version Adjustable heating tunnel Suitable bearings are used in place of bushings. Cost saving compared to other machines by 5 – 10% lower film consumption & savings on thermal heat energy

Pharmalab’s Monoblock is fitted with Filling & Sealing heads on a single base having common drive assembly to improve efficiency of filling & Sealing. The machine is suitable for syrup, suspension, foamy as well as viscous liquids. Pharmalab holds true to the tag line “We fill & seal any flow-able liquid in rigid container”. FEATURES GMP compliant compact design. Suitable for Plastic / HDPE / Glass bottles Fill sizes range from 30 to 500 ml , fill accuracy +/- 1% Same machine can cater to ROPP or Plastic/Screw Caps Output ranges from 40 to 280 bottles per minute Centralized arrangement for Height & volume Adjustment NO Bottle – NO Fill, NO bottle – NO cap, NO Cap Machine stop Auto level adjustment for overhead Filling hopper Safety cabinet Fault alarm system Quick change over Wash cycle thru PLC PLC controlled Automatic cap loading system ( optional)

We are offering sanitary centrifugal pumps. Centrifugal pumps are a popular choice for low viscosity (thin) liquids that need to be pumped at high flow rates. Centrifugal pumps are often used in many industrial, municipal and commercial applications and are usually quick to install and easy to repair.

Rubber Stoppers (Bungs) are mainly used in stoppering vials and it is necessary tosterilize these as they are in direct contact with the product.Though the trend of using pre-sterilized bungs from the market is still prevalent, their viability is still a question, owing to the various handling & transportation issues leading to questions on sterility. Pharmalab’s unique Bung Processor along with a sterilizer enables customers to reap benefits of ‘twin processes’ from single machine.The bungs are loaded into a ‘drum’ and later placed into the sterilizer. The entire operation is done via PLC wherein the pre-set program determines the wash sequence (Eg. Detergent Wash, WFI Wash & Silicon Treatment) followed by a final sterilization using HPHV cycle.This ensures complete sterility for the bungs.These bungs can later be unloaded in “sterile pouches/bags” and transferred to the filling room, usually under laminar air flow conditions. Keeping ‘ease of operation’ in view, Pharmalab has designed a unique ‘drum’ that has the capability for auto unloading of the bungs, which eliminates the intermediate ‘handling’ of bungs.Also, with Pharmalab’sexpertise you can look forward to special feature like preservative & Hot Air treatment with HEPA Filters for enhanced results.

The sophisticated design of “Pharmalab Rotary Vacuum Drum Filter (RVDF)”is user friendly as it reduces manual operation by providing automated slurry level maintenance in the trough, automated transfer of filtrate from vacuum tank and automatic cake discharge arrangement. The trough is provided with tilt arrangement to control the immersion, reduce dead time between the cake discharge and drum immersion for new cycle to start and increase drying time.   SALIENT FEATURES Compact and Hygienic design for Pharmaceuticals and Food & Beverage processing Automated, Sophisticated and User friendly operation Variable Drum speed from 0.5 to 5 rpm Trough tilt up to stipulated degree to choose proper drum immersion degree. Reduces the dead time and achieve better drying of cake. Automated level regulation in trough Complete draining of filtrate from drum filter Automated cake cutting blade advancement system Anti-foaming arrangement in Vacuum tank. Wear resistant cake cutting knives using special abrasion proof material Cake discharge belt conveyor arrangement (Optional) Simple and easy to operate APPLICATION Dewatering, washing and /or clarification. Bulk filtration in Pharmaceutical industry. Clarification of fruit juices in food processing Fermented lees filtration in wine industry Trub filtration and wort separation in breweries Recovery of liquid from brewery waste Corn syrup clarification Removal of fats, oils, protein, and unconverted starch from neutralized sugar liquor Dextrose clarification Filtration of liquid sugar and molasses Dewatering slurries of food & pulp Biomass recovery in breweries  

Rotary Indexing Type Bottle Washing Machine is specially designed for the output upto 96 BPM of different sizes of bottles. Machine has provision for 4 types of internal and one external washes, of different media without mixing of wash media. This is GMP model, with water saving, jump protection (for plastic bottles), filters, etc. as optional features. Loading and unloading of bottles is manual.   SALIENT FEATURES No mixing of washing media. Each wash at two stations. Common Neck Holder upto 28 mm. Easy changes over. Material of construction S.S. 304 or S.S. 316. Optional features – Water saving features, filters, hot water wash etc.. No skill required for operating the machine. Suitable for Pet bottles also. For bottle dia. above 90 mm – different model available.

We are offering pharmaceutical process equipment is equipment used in chemical and materials processing for manufacturing pharmaceutical products. The machines and equipment that pharmalab india manufactures is usually designed with a specific process or family of processes in mind and can be customized for a particular facility in some cases.

FEATURES Dead leg & Crevice free Mirror polished contact surface as per cGMP criteria 100% Aseptic and Hygeinic Design as per USFDA 3A, EHEDG, ASME (BPE) Norms 100% cleanable & sterilizable Electropolished inside surface to Comfortable handling Specially designed Pressure Vessel suitable for In-situ sterilization Complete set of filtration equipment with Pressure Vessel + Membrane Filter Holder + Sterile Filling Vessels can be supplied SPECIFICATIONS We provide complete range of Aseptic and sterile SS containers for Pressure Filling Vessels for handling Injectable Liquids under highest grade classified area Dispensing Nozzle with Dip Tube Pressure Nozzle with Clamp Handle for Lifting/Shifting SS Trolley with PU Castors Sight Glass (Optional) Safety Valve Vertical, Cylindrical with Conical / Dish top and shallow dish bottom with skirt Top opening with T/C clamped with skirt Contact parts: SS 316L, Mirror polished to 0.3 Micron RA Non-Contact parts: SS 304 Matte finished to 0.8 Micron Gasket: Food Grade Silicone Dynamic Working of 3.5 to 4 Barg Pressure and partial vacuum 5 L to 250 L

 Our plants meet the cGMP, FDA and USFDA guidelines as well as ASME requirements. Our equipment is designed based on principle of Distillation by Thin Film Evaporation. Our plants fit your requirements and follow the most common procedures for the production of water for injection and pure steam for their application in the pharmaceutical industry. Some of our special features are Pharmalab India uses a unique three stage pyrogen removal system A specially designed centrifugal separation followed by separators. Unique purging system for removal of impure water. Both pure steam and water for injection (WFI) are used in many areas of the pharmaceutical industry. Pure steam is mainly used for sterilizing tanks, filters, piping systems and also for the products in sterilizers. Moreover, it is even used for air-moistening in cleanroom systems. WFI is used for the production of medicaments and intermediates, as well as for the final cleaning of equipment. Our Multi Column Distillation Stills and the Pure Steam Generator have seen more than 2500 installations across the globe and are our flagship products. Get in touch with us to work with our specialised engineers to get the right plant for your unique requirements.

Sterilization (or sterilisation) in simple terms, refers to any process that effectively kills or eliminates transmissible agents (such as bacteria, viruses, sporeforms etc.) from a surface, equipment or biological culture medium. This aspect of sterilisation is critical for the pharmaceutical manufacturing and sterile processing equipment is the cornerstone of the pharmaceutical industry. Every year more pharmaceutical products are recalled for a single reason – they fail the Sterility Assurance Test. Sterilization can be achieved through application of heat, chemicals, irradiation, or filtration. Of these, heat(steam) sterilization is proven to be the most effective. At Pharmalab India, our sterilizers have been engineered to meet the stringent manufacturing standards, like cGMP, EN285 (European), MHRA (UK), FDA (US), and most of the guidelines being followed by the Pharmaceutical & Bio-tech industries. Pharmalab India believes in “Total Quality”and “Total Customer Satisfaction”, hence manufacturing is in accordance with GAMP & ISO 9001 guidelines & our provision of documentation (Like DQ, QQ, lQ) enables customer to meet the above standards.

We offer you highly qualified technical services in every aspect to meet the highest criteria of sterility in minute design as well as all the required specifications with innovative and efficient process technology for Parenterals applications in complete compliance with WHO, USFDA and MHRA regulations. The equipments are designed as per ASME guidelines. Our range of expertise starts from Designing, Developing, Manufacturing in strict cGMP compliance, carrying out FATs, supplying and supervising site erection with the execution of sterile piping and Automation System for the latest high quality LVP Process Plants with all the required qualification documents. The Automation System is designed as per GAMP, 21 CFR Part 11 compliant (Optional) Detail Design & Engineering Automation Manufacturing Qualifications Installation Supervision Piping Systems CIP & SIP Systems Assistance in validation CE” marked Equipments are offered with Third Party Inspection & All Electrical Control with ERTL Approval & Test After Sales Services SPECIFICATIONS Crevices and dead leg free contact surfaces, electropolished from inside 100% Drainability Completely suitable for CIP & SIP Aseptic Sampling facility Flush mounted Tank Bottom Diaphragm Valve Sterile Micron Filtration System Food Grade Gaskets in compliance with FDA 21 CFR Part 177-2600 State-of-the-Art Bottom Entry Mixing System with Sterile Double Mechanical Seals OR Bottom Magnetic Stirrers Vacuum Powder Addition System APPLICATIONS: Infusion Solution Electrolytes De-aeration

We offer packaging.pharmalab has dedicated its engineering capabilities and expertise for developing high speed machines to meet the industry needs. The supply of machines is supported by a strong technical team for installation of the machines as well as training of the operating staff.